Quality Management Systems (QMS System)

Quality Management Software Systems by MasterControl Organizes Documents, Process and Procedures to Meet Regulatory Requirements of a QMS System

A quality management system (QMS), according to the American Society for Quality (ASQ), is “a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS system helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

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Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
Automating Quality Compliance and Business Process within the Food and Beverage Industry
5 Tips for Getting Executive Backing for a New or Expanded EQMS
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MasterControl Quality Management System (QMS) Overview

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Quality management systems serve many purposes, including:

Increasing efficiency

Engaging employees

Improving compliance

Improving processes

Accelerating time to market

The concept of total quality and quality management implementation took off in earnest after World War II, just as W. Edwards Deming was shaping a quality movement in Japan. Deming, a world-famous proponent of quality control, focused on improving all processes from the get-go instead of waiting for product inspection at the end of the manufacturing process. Deming’s concept has had a great impact on implementing quality management systems in the manufacturing world.

Implementing Quality Management Systems that Bring Real Improvements

Many quality professionals don’t feel that a process is complete until a signature has been inked on a paper form. They’re daunted by the very idea of implementing quality management systems (QMS) that are electronically based. What they may not be considering, though, is that a robust quality management software solution makes it possible for a company to enhance the efficiency of its quality management systems while also ensuring that those systems are compliant, connected, and cost effective. Implementing quality management systems that automate quality processes allows companies to keep up with industry trends and gives them a proven means of achieving and maintaining regulatory compliance. The question, then, is how does a company go about implementing QMS software? Where do you start?

What to Do When Implementing Quality Management Systems

To ease some of the anxiety about implementing quality management systems, consider some of the key factors that need to be reviewed before taking the plunge and abandoning your antiquated paper-based QMS system:

Establish the scope: Carefully defining your quality management criteria is the first step completed before implementing quality management systems. If you don’t analyze your needs and define your direction and criteria, you won’t know the type of electronic QMS system that best fits your needs.

Determine your number one priority: Typically, a company will have one of three top priorities when implementing quality management systems: money, time, or process. If you can’t determine which priority is number one prior to implementing the quality management system, the conflict will inevitably result in failure in at least one department once implementation is complete. If the company is facing a deadline due to an audit finding, then time is the top priority. If internal inefficiencies and broken processes are continually the company’s biggest bugaboos, then process is the top priority. If you know you need a modern, automated quality management system but you only have a limited budget, then money is your chief concern. Whatever the priority may be, it needs to be defined prior to implementation.

Review all the issues: If you are unable to clarify the “what” and the “why” of your implementation project, you will never be able to find a resolution. Defining and reviewing your requirements, constraints, and procedures will narrow your focus to just the core issues. Don’t take a single step toward implementing quality management systems until such issues have been reviewed.

Plan with clarity: Ever hear the adage “Measure twice, cut once”? The same concept applies when implementing quality management systems. You’ll just end up wasting money and resources if you don’t double check and clearly establish your focus and central problems. Take Company X, for instance. They thought an expensive QMS software solution that had all the best bells and whistles would resolve all their quality headaches. Unfortunately, they didn’t identify that the main problem wasn’t the quality management system they were using; rather, it was a broken quality process. As a result, the pricey new system didn’t solve the problem, it was merely incorporated into an already flawed process.

Exploit the advantages of team decision making: If your decision-making team takes the time to uncover all the expectations and possible contingencies, you won’t need to sugar coat the return on investment because all bases have been covered and all departments’ needs have been addressed.

Don’t discount the value of good resources: Don’t leave internal subject matter experts (SMEs) out of the decision-making process just because you’re worried about having too many cooks in the kitchen. On the flip side of that coin, however, you may think you have everything under control with internal resources, but don’t dismiss what an outside expert can bring to the table when considering implementing quality management systems.

Get the proper consensus: If you always make sure you’ve taken the time to have all appropriate personnel review and define their actual needs, you’ll have ensured that the proper amount of resources have been assigned to your implementation project and things will only have to be done once because you’ve done them the right way.

Don’t ignore collective experience: The key to success in any business is using the right person for the right job. Don’t ignore all the experience and expertise that industry SMEs can bring to the table.

Never force a square peg in a round hole: The whole point of implementing quality management systems is to improve quality processes, so don’t try to force current inefficient processes into an improved electronic system. Instead, focus on adjusting processes, improving them to fit the new software system.

These are just a handful of tips to consider when implementing quality management systems. Whatever choices you ultimately make, always remember the bottom-line rationale of QMS implementation: with the set of QMS management tools that most appropriately meets organizational needs, a company can dramatically improve both product quality and speed to market. If the right preparations and precautions are taken before implementing a quality management system, it’s possible for companies to manufacture more products of a higher quality at a much lower cost.

Implementing Quality Management Systems for Pharmaceutical Companies

In the pharmaceutical industry, there are two widely used documents that provide guidance for implementing quality management systems: Q10 Pharmaceutical Quality Management System and “Quality Systems Approach to Pharmaceutical CGMP Regulations.

Q10 refers to “ICH Q10,” which describes a comprehensive model for an effective quality management system for the pharmaceutical industry based on ISO standards quality concepts. Q10 is considered a model system for quality management implementation and it can be implemented through the different stages of a product lifecycle.

The FDA’s “Quality Systems Approach to Pharmaceutical CGMP Regulations” is a guidance designed to explain how manufacturers implementing quality management systems can comply with 21 CFR Part 211. The guidance defines quality concepts of a modern quality system, such as quality by design, risk management, CAPA, change control, and the six-system inspection unit.

For medical device manufacturers, the FDA’s 21 CFR 820 (Quality System Regulation or QSR) and 1SO 13485 are two of the most widely applied regulations and standards for implementing quality management systems.

21 CFR 820 identifies the essential elements of a good quality system, but it leaves manufacturers enough leeway to develop specific procedures for quality management implementation. The FDA’s Medical Device Quality Systems Manual also provides guidelines for implementing quality management systems and should be used by device firms in conjunction with QSR.

ISO 13485 outlines the requirements for device manufacturers in implementing quality management systems, including requirements pertaining to management, resources, remediation, and the quality system itself. For device manufacturers located in the U.S. or selling their products in the U.S., complying with both ISO 13485 and 21 CFR 820 is easier with the FDA’s harmonization of QSR with ISO standards.

Implementing Quality Management Systems with the Help of MasterControl

Cloud-Based Services: Implementing quality management systems doesn’t have to be cost prohibitive. For small and other companies concerned about the high cost of owning a QMS, MasterControl offers cloud-based services. A cloud-based QMS system offers the same robust system in a secure environment without the need for a huge, up-front cost of, or a large IT staff.

Education Services: To support customers’ quality management implementation efforts, MasterControl offers intensive training for system administrators, quality professionals, and other MasterControl users. The Education Services team conducts software training either at the customer’s facility or at MasterControl’s Salt Lake City headquarters.

MasterControl provides a complete solution to facilitate quality management implementation. To learn more about MasterControl, contact a MasterControl representative.

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.